With the issuance of the “Notice on the First Batch of the Significant New Drugs Development Programs Under Major National Science and Technology Programs to be Launched in 2018” by the Development Center for Medical Science and Technology, National Health and Family Planning Commission of the PRC recently, Suzhou Kintor Pharmaceuticals, Inc. (“Kintor”) is pleased to announce that the clinical trial of ALK-1 monoclonal antibody inhibitor, a Category 1 new drug (project code: GT900001) has been selected as a state-subsidized project. This is also Kintor’s second project receiving support from the “Significant New Drugs Development” program under the 13th five-year plan, following the inclusion of the clinical trial of its Category 1.1 new drug for prostate cancer and breast cancer, Proxalutamide. It is also Kintor’s third new drug development project receiving state support from the “Significant New Drug Development” program.
About ALK-1 monoclonal antibody inhibitor
In January 2018, Kintor was granted the exclusive worldwide rights to develop, manufacture and commercialize an ALK-1 (Activin receptor-like kinase-1) antibody drug by Pfizer Inc. (“Pfizer”), marking Pfizer’s first license extended to a local Chinese pharmaceutical business for the worldwide development of a new antibody drug in tumor therapy. The drug is expected to become the world’s first fully human therapeutic monoclonal antibody that targets ALK-1, with the potential to treat various types of advanced solid tumors by applying combo therapy with VEGF inhibitors or PD-1/PD-L1 inhibitors.
Pfizer-Kintor Press Conference on Development of an Innovative Antibody Drug for Cancer
Based on Pfizer’s Phase-I trial results, Kintor will conduct multi-center Phase-II clinical trials as well as joint clinical trials of different combination regimens across the world. On 15 November 2018, Kintor received approval from Taiwan Food and Drug Administration (“Taiwan FDA”) for its ALK-1 and PD-1 joint clinical trial for the treatment of liver cancer, with Professor Xu Jun from National Taiwan University to act as the Principal Investigator in the Phase-II trial. Kintor has also submitted a Multi-regional Clinical Trial (“MRCT”) application to National Medical Products Administration (“NMPA”) of China for the single therapy and combination regimens. Moreover, Kintor is also actively expanding and exploring the drug’s clinical applications in addition to liver cancer (such as renal cancer, breast cancer and prostate cancer) to deliver benefits to patients as early as possible.
About Kintor’s inclusion in the “Significant New Drugs Development” program
The “Significant New Drugs Development” program is an important strategy of the state to foster innovation-driven sustainable growth. By subsidizing the production of a variety of significant drugs, the program hopes to accelerate the growth of China’s pharmaceutical sector, cultivate a group of key enterprises with strong international competitiveness, and elevate China’s independent drug innovation systems and capabilities to match or close to the best in the world.
Since its establishment, Kintor has been committed to developing the optimal therapeutic solutions for more than 50 percent of patients with critical malignant tumors across the world. Apart from ALK-1 antibody, its key drug candidate Proxalutamide is a Category 1.1 new drug which has obtained over 40 patents worldwide. In 2011 and 2017, the Proxalutamide project was granted state subsidies from the “Significant New Drugs Development” programs under the 12th and 13th five-year plans respectively. So far, the Phase-III clinical trials of Proxalutamide as second-line and front-line therapies for mCRPC indications have kicked off in May and October 2018 respectively; the Phase-I/Ib clinical trial of Proxalutamide for metastatic breast cancer indications is being conducted; and the Phase-Ic clinical trial of a combination regimen is expected to start in March 2019.
The inclusion of the ALK-1 project in the “Significant New Drugs Development” program once again symbolizes recognition of Kintor’s new drug development effort over the years. Dr. Tong Youzhi, Chairman & CEO of Kintor and the Project Principal comments, “We shall seize this opportunity to continuously improve our clinical R&D capabilities, explore safer and more efficacious cancer therapies for patients and try our best effort to deliver locally developed new drugs affordable to common people as early as possible!”